FDA.reportPublic FDA data

AUVON

Primary DI
00850080988398
Brand
AUVON
Company
UAN HEALTHCARE LIMITED
Model
TX6224
Device description
1) TENS The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. 2) EMS The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
Published
2026-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NGXStimulator, Muscle, Powered, For Muscle Conditioning
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243763000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243763000Wireless TENS & EMS UnitChangsha Anxiang Medical Technology Co., Ltd.2025-03-12NGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850080988395PackageGS148In Commercial Distribution
00850080988398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085008098839510850080988395
00850080988398008500809883988500809883980850080988398

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Contacts#

Phone, Email table
PhoneEmail
+1(678)829-7256support@iauvon.com

Regulatory Flags#

DUNS number
765349382
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850080988466AUVONTA22242026-05-24
00850080988435AUVONTA22242026-05-21
00850080988442AUVONTX62242026-05-21
00850080988459AUVONTX62242026-05-21
00850080988428AUVONDS-W2026-05-09
00850080988411AUVONTU24242026-05-06
00850080988381AUVONTA22242026-04-29
00850080988404AUVONTP2208C2026-04-29
00850080988206AUVONEB15202026-04-07
00850080988213AUVONEB1M202026-04-07
00850080988190AUVONEB15202026-03-30
00850080988152AUVONEB1M202026-03-27
00850080988169AUVONEB10102026-03-27
00850080988176AUVONEB15202026-03-27
00850080988183AUVONEB15202026-03-27
00850080988145AUVONTX62242026-03-23
10850080988142AUVONTX62242026-03-23
00850080988138AUVONTP2408C2026-03-19
10850080988135AUVONTP2408C2026-03-19
00850080988107AUVONDS-W2026-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199874125305Muscle StimulatorShenzhen Yiran Intelligence Co., Ltd.NGX2026-05-08
00194346404155EquateWAL-MART STORES, INC.NUH2026-05-01
00810060832851Venus NovaVenus Concept Inc.NGX2026-04-15
00810093080786PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810093080793PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810140062680RENPHOJoicom CorporationNUH2025-10-20
00810140062680RENPHOJoicom CorporationNGX2025-10-20
00810140062697RENPHOJoicom CorporationNUH2025-10-20
00810140062697RENPHOJoicom CorporationNGX2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NUH2025-10-03
00810113683782ManaRecovery Stimulation System Manamed, Inc.NGX2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NUH2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NGX2025-10-03
00092237621967TwinStimDrive Devilbiss HealthcareNGX2025-09-29
00092237621967TwinStimDrive Devilbiss HealthcareNUH2025-09-29
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NGX2025-09-11
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NUH2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.NUH2025-09-11
00810113683379DualPulse CompactManamed, Inc.NUH2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.NUH2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.NUH2025-08-21
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.NGX2025-08-21
00092237621974TwinStimDrive Devilbiss HealthcareNUH2025-08-15
00092237621974TwinStimDrive Devilbiss HealthcareNGX2025-08-15
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.NGX2025-07-21
00194346469680EQUATEWAL-MART STORES, INC.NGX2025-06-13
00810038637365easy@Home TENS AND MUSCLE STIMULATOREASY HEALTHCARE CORPORATIONNUH2025-04-17
16971712727657AUVONHong Qiangxing (Shen Zhen) Electronics LimitedNUH2025-03-31
16971712727657AUVONHong Qiangxing (Shen Zhen) Electronics LimitedNGX2025-03-31
00768627001632NorcoNORTH COAST MEDICAL, INC.NGX2025-03-26